Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Afirma™ Assay by Veracyte

A54358

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Contractor Information

Article Information

General Information

Article ID
A54358
Article Title
Billing and Coding: MolDX: Afirma™ Assay by Veracyte
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2021
Revision Ending Date
N/A
Retirement Date
N/A
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CMS National Coverage Policy

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Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

The MolDX Team has completed the Afirma assessment and determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit. Effective 10/01/2015, MolDX will reimburse Afirma services for patients with the following conditions (patient must have 1 and 2):

1. Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:

  • Nodule growth over time
  • Family history of thyroid cancer
  • Hoarseness, difficulty swallowing or breathing
  • History of exposure to ionizing radiationHard nodule compared with rest of gland consistency
  • Presence of cervical adenopathy

2. Have an indeterminate follicular pathology on fine needle aspiration

MolDX expects this test will be performed once per patient lifetime. Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with support documentation.

To report an Afirma service, submit the following claim information:

  • Select the appropriate CPT® code.
  • Select the appropriate ICD-10-CM diagnosis
  • Enter the DEX Z-Code™ identifier in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Item 19 for paper claim
  • Enter the DEX Z-Code™ identifier in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
81546 ONCOLOGY (THYROID), MRNA, GENE EXPRESSION ANALYSIS OF 10,196 GENES, UTILIZING FINE NEEDLE ASPIRATE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (EG, BENIGN OR SUSPICIOUS)

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(11 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
D34 Benign neoplasm of thyroid gland
D44.0 Neoplasm of uncertain behavior of thyroid gland
D44.9 Neoplasm of uncertain behavior of unspecified endocrine gland
E01.0 Iodine-deficiency related diffuse (endemic) goiter
E01.1 Iodine-deficiency related multinodular (endemic) goiter
E01.2 Iodine-deficiency related (endemic) goiter, unspecified
E04.0 Nontoxic diffuse goiter
E04.1 Nontoxic single thyroid nodule
E04.2 Nontoxic multinodular goiter
E04.8 Other specified nontoxic goiter
E04.9 Nontoxic goiter, unspecified

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

CodeDescription
018x Hospital - Swing Beds

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2021 R6

Under Article Text: Added bullet to read “Select the appropriate CPT® code”

01/01/2021 R5

81545 was deleted and 81546 was added to Group I Codes. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is effective for dates of service on or after 01/01/2021.

11/01/2019 R4

As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.

09/20/2018 R3

Reimbursement and coverage is clarified to require a condition from 1. and 2. Effective 09/20/2018.

01/05/2018 R2

Article is updated to add Part A claim filing information.

Article number A54357 for Jurisdiction F Part A (JFA) was retired on January 5, 2018, and combined into Jurisdiction F Part B (JFB) article number A54358.  JFA and JFB contract numbers will have the same final MCD article number and remain an Active article. Coverage will remain the same.


 

01/01/2016 R1 Article is revised to replace 81479 with 81545 effective 01/01/2016.

Associated Documents

Related Local Coverage Documents
LCDs
L36256 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
02/16/2021 01/01/2021 - N/A Currently in Effect You are here
02/09/2021 01/01/2021 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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